Dual SSTR2 and Integrin αvβ3 Targeting PET/CT Imaging

Early Phase 1

• Conditions: Neuroendocrine Neoplasm; Lung Cancer
• Interventions: Drug: 68Ga-NOTA-3P-TATE-RGD

• Registration Number: NCT02817945
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluate the efficacy of 68Ga-NOTA-3PTATE-RGD in lung cancer patients and neuroendocrine neoplam patients. A single dose of 111-185 Mega-Becquerel (MBq) 68Ga-NOTA-3P-TATE-RGD will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.

Detailed Description

The number of somatostatin receptors may be greatly up-regulated in the cells of a variety of tumor including carcinoids, gastrinomas, paragangliomas, small cell lung cancer and non-small cell lung cancer. Octreotide is an eight amino acid cyclic peptide that preserves a four amino acid motif (Phe-Trp-Lys-Thr) that is critical for the biological activity of somatostatin (SSTR). On the other hand, the RGD moiety binds with integrin αvβ3, also plays an important role in the regulation of tumor growth, angiogenesis, local invasiveness, and metastatic potential in human tumor. To target both receptors, a heterodimeric peptide TATE-RGD was synthesized from TATE and RGD through a glutamate linker and then labeled with 68Ga. An open-label whole-body PET/ CT study was designed to investigate the safety and dosimetry of 68Ga-NOTA-3PTATE-RGD and diagnostic performance of 68Ga-NOTA-3PTATE-RGD PET/CT in evaluation of lung cancer and neuroendocrine neoplams.

Study Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-06-27
• Study First Posted: 2016-06-29
• Primary Completion: 2020-12-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-30
• Last Update Posted: 2022-04-07
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Neoplasm identified by X-ray, ultrasound or MRI as lung cancer or neuroendocrine tumors
• To provide basic information and sign the written informed consent.

Exclusion Criteria

• Consisted of conditions of mental illness;
• Severe liver or kidney disease with serum creatinine > 3.0 mg/dl (270 μΜ) or any hepatic enzyme level 5 times or more than normal upper limit;
• Severe allergy or hypersensitivity to IV radiographic contrast
• Claustrophobia to accept the PET/CT scanning
• Pregnancy or breast feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-NOTA-3P-TATE-RGD PET/CT	68Ga-NOTA-3P-TATE-RGD	The patients were injected with 111-185 MBq of 68Ga-NOTA-3P-TATE-RGD in one dose intravenously and underwent PET/CT scan 45-60 min later.

Primary Outcome Measures

Name	Time	Method
Standardized uptake value of 68Ga-NOTA-3PTATE-RGD in lung cancer and Neuroendocrine Neoplasm	1 year	The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in breast cancer will be measured.

Trial Locations

Locations (1)

Peking Union Medical College Hospitall, Chinese Academy of Medical Science and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China